Oral budesonide for treatment of autoimmune chronic active hepatitis

To see if budesonide, a second generation glucocorticosteroid with a high topical effect and a high first-pass metabolism of 90% in the healthy liver, can induce biochemical remission in autoimmune chronic active hepatitis before being metabolized, and further to study the effect on endogenous plasma cortisol levels and corticosteroid-related side effects.

Thirteen patients with autoimmune chronic active hepatitis (11 females) were treated openly for up to 9 months by oral budesonide capsules. The initial dose was 6-8 mg (mean 6.3 mg) daily for 6-10 weeks, and then the dose was individualized.

The pre-treatment values of alanine aminotransferase and immunoglobulin (IgG) were 7.1 +/- 1.2 mukat/L (mean +/- S.E.M.) and 26.4 +/- 3.9 g/L, respectively. After 6 weeks of treatment, significant decreases in alanine aminotransferase (to 2.1 +/- 0.9 mukat/L) and immunoglobulin (to 18.4 +/- 2.4 g/L) were recorded. After 9 months the corresponding values (n = 9) were 1.2 +/- 0.9 mukat/L and 15.9 +/- 1.3 g/L, respectively. The mean value of plasma cortisol remained within normal ranges or was only slightly subnormal for the whole group (364 +/- 44 nmol/L at start, 165 +/- 46 after 6 weeks and 138 +/- 48 after 9 months). However, significantly reduced plasma cortisol levels were found in patients with biopsy-proven liver cirrhosis.

Oral budesonide appears to decrease liver inflammation in autoimmune chronic active hepatitis while causing a low frequency of systemic side effects and a marginal reduction in plasma cortisol in noncirrhotic patients over a study period of 9 months.